On the heels of last month's announcement that California would extend its deadline for total e-pedigree integration to 2011, Congress is considering a bill that would make e-pedigree standard throughout the United States.
The bipartisan sponsored House bill 5839, entitled "Safeguarding America's Pharmaceuticals Act," calls for a closed-loop, track-and-trace pedigree system using item-level serialization. Basically, every drug that goes through the supply chain will need to be tracked as it travels from point to point.
The major impact will be at the state level, as the bill says that no state or non-federal body can establish a pedigree system separate from the federal standards. That means that e-pedigree regulations in California and Florida would have to be modified or killed altogether.
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"This kind of tracking is inevitable," said John Beans, vice president of marketing at serialization solutions provider Blue Vector. "It's yet another signal that everyone wants drugs tracked at the item level."
State By State
California's law is partially in line with the proposed federal legislation in that it mandates that all drugs passing through the state have some form of serialization, so they can be tracked from the pharmaceutical manufacturer right up to the point of dispensing.
However, the federal law specifies that the pedigree begin with the authorized distributor of record, not the pharmaceutical company. This is more in line with Florida's pedigree law.
Most industry concern has centered on time and cost of implementing the e-pedigree system. Pharma companies struggled to get every line and distribution center compliant with California law by the original deadline of January 2009—and most failed. The extension to 2011 buys a little more time, and the federal law, if passed, will probably buy them more. Still, companies will need to have every drug tagged well in advance to avoid having unserialized drugs in the supply chain when the due date comes.
The Early Birds
"An approach that is consistent across the country is a good idea," said Brenda Kelly, director of marketing at Supplyscape, a supply chain software provider. "The devil is in the details, and having the different supply chain segments agree on a single approach is important."
Early adopters of e-pedigree in the pharma industry had to figure out serialization for themselves. Purdue uses ultra-high frequency tags to track every bottle of Oxycontin, while Pfizer uses high frequency RFID chips to track Viagra, and other companies use 2D bar codes. Meanwhile, distributors have been forced to install systems that handle everything—while racking up huge infrastructure bills.
"If you're going to adopt technology, then you want to do it with an eye toward making sure that the technology not only meets the compliance requirements, but also gives a company a foundation for business value going forward," Kelly said.
Many companies have taken a phased approach, serializing some products and adding a pedigree to everything. This improves patient safety and shows an effort to move forward.
"Now that the time frame has shifted, they have a lot more work to do, because everything must be serialized by that deadline," Kelly said. "Partial compliance is not an option."